| Primary Device ID | 00858985006063 |
| NIH Device Record Key | 01d6bced-a831-4a5e-8ea3-03e5cb04e6b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PL Touch |
| Version Model Number | PLT |
| Catalog Number | PLT |
| Company DUNS | 004053174 |
| Company Name | ERCHONIA CORPORATION, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 00858985006261 - Erchonia Zerona Z-Bed | 2022-11-08 AESTHETIC - Floor Model Low Level Laser -- 12 diodes 640nm 17mW - OTC (Non-prescriptive) - IFU Reduction Circumference |
| 00858985006278 - Erchonia GVL | 2022-11-08 MEDICAL - Handheld Low Level Laser - 2 diodes 520nm & 405 nm 7.5 mW - includes induction charger - IFU Reduction Pain, and treat |
| 00858985006193 - FX405 | 2020-08-18 MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - 1 diode 23mW 405nm - IFU Pain Reduction, Acne Reduction |
| 00858985006155 - Adjustor | 2020-06-29 THERAPEUTIC – Handheld Variable Adjuster – IFU adjunctive use for treatment of symptoms associate with pain |
| 00858985006162 - Percussor | 2020-06-29 THERAPEUTIC – Handheld Galvanic Massager – IFU temporary reduction of the appearance of cellulite |
| 00858985006186 - FX635 | 2020-06-29 MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - IFU Pain Reduction |
| 00858985006018 - Emerald | 2020-01-16 AESTHETIC - Floor Model Low Level Laser -- 10 diodes 532nm 17mW - IFU Reduction BMI +30 or greater |
| 00858985006049 - FX635 | 2019-09-09 MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - IFU Reduction of Musculoskeletal Pain |